Objectives: To perform clinical and echocardiographic follow-up beyond 1 year in consecutive patients with severe bicuspid aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) with a current generation balloon-expandable valve.Background: Treatment of bicuspid aortic valve disease with TAVR remains controversial and late follow-up data is still scarce.
Methods:We collected baseline characteristics, procedural data, 30-day and midterm clinical follow-up findings from six centers in Europe and Canada from patients with bicuspid AS treated with TAVR using the SAPIEN 3 valve.Results: Seventy-nine patients underwent TAVR. Mean age was 76 ± 9 years; median STS risk score for mortality was 3.8% (interquartile range 2.3-5.5%). Median follow-up was 390 days (interquartile range 138-739 days). Device success was achieved in 95% of patients. Postimplantation mean aortic gradient decreased from 50.2 ± 16.2 to 8.8 ± 4.4 mmHg and no patient had more than mild aortic regurgitation. At last follow-up, there was persistent good valve performance. At 30 days and 1 year, the rates of allcause mortality were 3.8 and 7.7%, stroke 1.2 and 1.2%, and the rate of new pacemakers 18 and 18%.Conclusions: Our data confirm that treating patients with stenotic bicuspid aortic valves is safe, effective, and has favorable valve performance over time.aortic valve disease percutaneous intervention, paravalvular leak, structural heart disease intervention, transcatheter valve implantation Transcatheter aortic valve replacement (TAVR) has emerged as the preferred treatment modality for many patients with severe aortic stenosis (AS). 1-6 However, the great majority of data demonstrating efficacy and safety of TAVR derives from patients with tricuspid aortic valve morphology. Treatment of bicuspid aortic valve (BAV) disease with TAVR remains controversial. 7 BAV is a heritable defect found in 0.5-2% of the population. [8][9][10] Due to younger age at presentation and anatomical complexity, bicuspid AS has been excluded from major randomized trials comparing TAVR to surgical aortic valve replacement (SAVR). However, 2-6% of patients in large clinical registries have bicuspid AS. 11,12 Anatomical challenges associated with BAV include larger aortic annuli, severe and asymmetric leaflet and annular calcification, altered geometry, and dilation of the ascending aorta. 9,[13][14][15] In 2010, the first series of patients with BAV treated with early TAVR devices confirmed feasibility. 16 Typically, residual aortic regurgitation (AR) and periprocedural complications have been more common in patients with bicuspid AS undergoing TAVR. [16][17][18][19] However, this data is based on observational studies, in most of which, early generation devices were used. Perlman et al 20 demonstrated favorable periprocedural and 30-day outcomes in patients with BAV undergoing TAVR with the SAPIEN 3 valve, suggesting superior results with newergeneration devices. Subsequently, Yoon et al demonstrated improved procedural outcomes with the SAPIEN 3 val...